Evidence map›Paper›PMID 34496160›Full record

ArticleEthics & human research2021

A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid-19 Era.

Leonardo Tamariz, Fred J Hendler, John M Wells, Annette Anderson, Stephen Bartlett

Open access · bronzeAbstract read
In one paragraph

Article in Ethics & human research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 1 country.

Leonardo TamarizStaff physician at the Bruce Carter Veterans Affairs Medical Center and a professor in the Division of Cardiology at the University of Miami.
Fred J HendlerChief of hematology at the Robley Rex VA Medical Center.
John M WellsAssociate chief of research at the VA Bedford Healthcare System.
Annette AndersonAdministrator at the Office of Research Protections, Policy and Education at the Office of Research and Development in the U.S. Department of Veterans Affairs.
Stephen BartlettResearch pharmacy manager at the Rocky Mountain Regional VA Medical Center and an associate professor of clinical practice at the University of Colorado School of Medicine.
Bruce W. Carter VA Medical Center · USLouisville VA Medical Center · USUnited States Department of Veterans Affairs · USVA New England Healthcare System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

With the rapid spread of SARS-CoV2 has come a rapid proliferation of clinical research studies, resulting in considerable strain on research ethics committees (RECS), which need to review study proposals. RECs are pressured to move through the review process quickly so that studies can get underway to address the pandemic. These committees are also asked to increase efficiency without relaxing the standards for ethical review. RECs are accustomed to external pressure for approval from investigators; however, in the Covid-19 era, this pressure is coming from not only the sponsors and investigators but also many other stakeholders, including world leaders, the community, the media, and professional organizations. Drawing on the authors' experiences on a central REC reviewing complex multicenter Covid-19 studies, this commentary describes challenges that are inherent to Covid-19 research studies, such as the difficulty of obtaining informed consent from patients ill with the highly infectious virus. The commentary recommends several steps that RECs can take to ensure ethical review of research studies during the Covid-19 pandemic and future infectious disease outbreaks.

Indexed as

COVID-19Ethics, ResearchBiomedical ResearchEthics Committees, ResearchHumansInformed ConsentCovid-19 pandemichuman research ethicsinformed consentinstitutional review boards (IRBs)public health emergenciesresearch ethics committees (RECs)SARS-CoV2scientific validity

Identifiers

PMID34496160
PMCPMC8652905
OpenAlexW3196868417

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.